Home NDC 61010-5701 First Aid and Burn
Product NDC 61010-5701
11-digit product format 610105701
Labeler code 61010
Product ID 61010-5701_10d3fc91-82a0-e8eb-e063-6394a90ae87b
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride, Lidocaine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Safetec of America, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-09-21
Substance BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength 1.3; 5 mg/g; mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base First Aid and Burn
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/g LIDOCAINE HYDROCHLORIDE 5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012100 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-5701-3 First Aid and Burn 0.9 g in 1 PACKET CREAM 0.9 5 61010-5701-4 First Aid and Burn 144 in 1 BOX CREAM 144 5 61010-5701-5 First Aid and Burn 25 in 1 BOX CREAM 25 5 61010-5701-6 First Aid and Burn 10 in 1 BOX CREAM 10 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded benzalkonium chloride ACTIVE INGREDIENT F5UM2KM3W7 FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1 lidocaine hydrochloride ACTIVE INGREDIENT V13007Z41A FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1 benzalkonium ACTIVE MOIETY 7N6JUD5X6Y FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1 lidocaine ACTIVE MOIETY 98PI200987 FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1 alcohol INACTIVE INGREDIENT 3K9958V90M FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1 aloe vera leaf INACTIVE INGREDIENT ZY81Z83H0X FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1 mineral oil INACTIVE INGREDIENT T5L8T28FGP FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1 paraffin INACTIVE INGREDIENT I9O0E3H2ZE FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1 petrolatum INACTIVE INGREDIENT 4T6H12BN9U FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1 white wax INACTIVE INGREDIENT 7G1J5DA97F FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-5701 FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.] 5 Current NDC, Legacy NDC, 4 package rows 20240208_47cb6921-5d82-4123-a9e0-0b05d4dcb5b2.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 44 of 115 · 2,286 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61010-5701-3 61010570103 0.9 g in 1 PACKET 0.9 g Historical 61010-5701-4 61010570104 144 PACKET in 1 BOX (61010-5701-4) / .9 g in 1 PACKET (61010-5701-3) 144 packet 2012-09-21 0000-00-00 No No Current 61010-5701-5 61010570105 25 PACKET in 1 BOX (61010-5701-5) / .9 g in 1 PACKET (61010-5701-3) 25 packet 2012-09-21 0000-00-00 No No Current 61010-5701-6 61010570106 10 PACKET in 1 BOX (61010-5701-6) / .9 g in 1 PACKET (61010-5701-3) 10 packet 2020-04-01 0000-00-00 No No Current